MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7D282CT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a decanav electrophysiology catheter and during the operation, the device was unable to deflect or relax completely.The catheter curve was stuck in a deflected position.The knob/piston was unable to be turned and/or pushed up and down.A second device was used to complete the operation.There was no adverse event reported on patient.
Additional Manufacturer Narrative
On 26-mar-2025, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 28-apr-2025, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a decanav electrophysiology catheter and during the operation, the device was unable to deflect or relax completely.The catheter curve was stuck in a deflected position.The knob/piston was unable to be turned and/or pushed up and down.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and deflection test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis revealed that no damage or anomalies on the device.Deflection testing was performed, and the deflection was not stuck; however, the mechanism failed specifications due to curve being deformed, for this reason a manufacturing investigation was initiated.A manufacturing investigation was performed, and it was determined the issue is manufacturing related as damage in the puller wire at the tip area was observed upon dissection of the device, this damage may have occurred during the assembly process, thus, causing the deflection issue observed, this issue might be related to the issue reported.An awareness was performed for all the personnel involved.A manufacturing record evaluation was performed for the finished device 31510649m, and no internal action was found during the review.The deflection issue reported by the customer was confirmed.The potential cause was traced to manufacturing.This product issue will be addressed through j&j medtech's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21646249
• Report Number: 2029046-2025-00842
• Device Sequence Number: 7564821
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: (01)10846835008791(17)251124(10)31510649M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2025
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31510649M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 04/28/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/23/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown